← Back to Search

Alkylating agent

Selumetinib + Cisplatin/Gemcitabine for Biliary Cancer

Phase 2

Waitlist Available

Led By Jennifer Knox, M.D.

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unresectable, recurrent or metastatic, measurable biliary tract cancer or gall bladder cancer

Performance status 0, 1, or 2

Must not have

Prior chemotherapy for non-resectable or metastatic disease or a MEK inhibitor

Progressing within 6 months of adjuvant treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 weeks post initiation of therapy

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will compare two schedules of selumetinib given with cisplatin and gemcitabine to cisplatin and gemcitabine alone.

Who is the study for?

Adults with advanced biliary or gallbladder cancer who haven't had systemic therapy can join this trial. They should be in a condition to perform daily activities (performance status 0, 1, or 2), have an expected lifespan of over three months, and their blood counts and organ functions must meet certain standards. Pregnant women, those with recent other cancers, severe heart or eye conditions, uncontrolled diseases like hepatitis or HIV are excluded.

What is being tested?

This phase II study is testing the effectiveness of Selumetinib combined with Cisplatin/Gemcitabine versus just Cisplatin/Gemcitabine in patients. Selumetinib is taken orally and targets cell growth regulation while both Cisplatin and Gemcitabine are given intravenously to damage DNA in tumor cells.

What are the potential side effects?

Selumetinib may cause rash, fatigue, nausea, diarrhea; vision changes are also possible due to its effect on cell growth pathways. Cisplatin and Gemcitabine can lead to side effects such as kidney damage, hearing problems for the former; low blood counts causing infection risk for both.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer in the bile duct or gallbladder cannot be removed by surgery and has spread.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

I have not had any drug treatments that work throughout my body.

Select...

I do not have any ongoing infections that aren't under control.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had chemotherapy or a MEK inhibitor for cancer that couldn't be surgically removed.

Select...

My condition worsened within 6 months after my last cancer treatment.

Select...

I have never taken MEK, RAS, or RAF inhibitors and am not allergic to study drugs.

Select...

I do not have any ongoing infections, bleeding disorders, or a history of kidney transplant.

Select...

I have been diagnosed with ampullary carcinoma.

Select...

I have had problems with my eyes in the past.

Select...

I am currently receiving treatment aimed at curing my condition.

Select...

I have another cancer that might affect how my treatment response is measured.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks post initiation of therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 weeks post initiation of therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks post initiation of therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neoplasms

Side effects data

From 2012 Phase 2 trial • 37 Patients • NCT01085214

75%

Diarrhea

50%

Fatigue

47%

Anemia

47%

Rash acneiform

44%

Hypoalbuminemia

44%

Edema, limbs

39%

Aspartate aminotransferase increased

33%

Neutrophil count decreased

33%

White blood cell decreased

31%

Nausea

31%

Vomiting

28%

Platelet count decreased

25%

CPK increased

25%

Hypomagnesemia

22%

Hypertension

19%

Hypophosphatemia

19%

Hyponatremia

19%

Hypocalcemia

19%

Edema, face

17%

Dry skin

17%

Alanine aminotransferase increased

14%

Skin and subcutaneous tissue disorders - Other

14%

Hypokalemia

14%

Creatinine increased

14%

Back pain

14%

Dyspnea

14%

Lymphocyte count decreased

11%

Pain

11%

Fever

11%

Localized edema

11%

Peripheral sensory neuropathy

11%

Hyperkalemia

11%

Dizziness

11%

Abdominal pain

Anorexia

Hypoglycemia

Acute kidney injury

Death, NOS

Periorbital edema

Skin hypopigmentation

Pain in extremity

Cough

Insomnia

Alkaline phosphatase increased

Dry mouth

Sepsis

Hypernatremia

Metabolism and nutrition disorders - Other

Blood and lymphatic system disorders - Other

Renal and urinary disorders - Other

Hypercalcemia

Dehydration

Musculoskeletal and connective tissue disorder - Other, Rhabdomyolysis

Chills

Hypotension

Myalgia

Arthralgia

Upper respiratory infection

Headache

Sinusitis

Generalized muscle weakness

Gastrointestinal disorders - Other

Gastroesophageal reflux disease

Vaginal inflammation

Confusion

Pruritus

Febrile neutropenia

Flu like symptoms

Hepatic failure

Skin infection

Fall

Fracture

Skin and subcutaneous tissue disorders - Other, Angular cheilitis, unilateral

Adult respiratory distress syndrome

Renal and urinary disorders - Other, Acute renal failure

INR increased

100%

80%

60%

40%

20%

Study treatment Arm

AZD6244 (Selumetinib) Treatment

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C (Standard Care)Experimental Treatment2 Interventions

Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle.

Group II: Arm B (Sequential Dosing)Experimental Treatment3 Interventions

Run-In: Selumetinib, orally, BID for 5 days (Day -7 to Day -3) with 2 days washout On treatment: Selumetinib, orally, BID from Day 1-5 and 8-19 of every 28 day cycle. Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle.

Group III: Arm A (Continuous Dosing)Experimental Treatment3 Interventions

Run-In: Selumetinib, orally, BID for 7 days (Day -7 to Day -1) On treatment: Selumetinib, orally, BID from Day 1-21 of every 28 day cycle. Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Selumetinib

FDA approved

Cisplatin

FDA approved

Gemcitabine

FDA approved

0 / 13Eligibility criteria met